NCT04470024

Phase Ib Trial of Multivalent Autophagosome Vaccine With or Without GITR Agonist, With Anti-PD-1 Immunotherapy in HNSCC

A Phase Ib Study of Multivalent Autophagosome Vaccine, With or Without GITR Agonist, With Sequenced Checkpoint Inhibition (Anti-PD-1) - Immunotherapy Trio in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ib study with a safety lead-in (n = 6 per arm) evaluating combinatorial DPV-001 + sequenced PD-1 blockade, with or without GITR agonist, in recurrent or metastatic HNSCC.

Detailed description

This is a phase Ib trial of an autophagosome vaccine (DPV-001) with or without anti-GITR (INCAGN01876), combined with subsequent anti-PD1 (INCMGA00012), in patients with recurrent or metastatic HNSCC. Eligible patients will be registered and assigned to one of two treatment arms. Subjects in Arm 1 will receive combination therapy with DPV-001 with delayed anti-PD-1, and subjects in Arm 2 will receive DPV-001 and anti-GITR with delayed anti-PD-1 (triplet therapy). Mandatory biopsy will occur at week 2. Initial restaging CT and mandatory biopsy will occur at 8 weeks, followed by confirmatory CT at 12 weeks. Subsequent restaging CT will be performed at week 24 and every 12 weeks thereafter. Starting at week 22, dosing of DPV-101 will switch to a q4wk schedule, while the schedule of anti-GITR and anti-PD1 will remain unchanged.

Conditions

• Cancer of the Head and Neck

Interventions

Type	Name	Description
DRUG	INCAGN01876	agonistic antihuman GITR mAb
DRUG	INCMGA00012	humanized, hinge-stabilized, IgG4κ mAb that recognized human PD-1
BIOLOGICAL	DPV-001	autophagosome cancer vaccine

Timeline

• Start date: 2021-08-05
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2020-07-14
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study